BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2201772 · Received August 5, 2011

    Report

    Report Number
    3007566237-2011-06112
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    January 14, 2010
    Report Date
    July 15, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RESIDUAL VOLUME DISCREPANCIES WERE NOTED ON (B)(6) 2010. PATIENT SEVERITY WAS MILD. THE OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2010. AS PER THE MANUFACTURER'S DEVICE REGISTRATION SYSTEM THE DEVICE WAS REPLACED ON (B)(6) 2010. THE DRUGS INFUSED VIA THE PUMP WERE FENTANYL 1,000.0 MCG/ML, BUPIVACAINE 4.0 MG/ML AND CLONIDINE 250.0 MCG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8731, LOT# N001400719| EXPLANTED: